Device and method for deploying and attaching an implant to a biological tissue

ABSTRACT

This present invention generally relates to devices and methods for repairing an aperture in a biological tissue. In certain embodiments, the invention provides a system for closing an aperture in a biological tissue including a handle, an elongate shaft connected to the handle, and a deployment scaffold connected to the shaft, in which the scaffold is configured to releasably retain a surgical implant and the scaffold is configured to deploy and attach the surgical implant to the biological tissue.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/834,456, filed Jul. 12, 2010, which is a continuation-in-part ofPCT international patent application number PCT/IL2009/000188, filedFeb. 18, 2009, which claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 61/029,386, filed Feb. 18, 2008,the content of each of which is incorporated by reference herein in itsentirety.

FIELD OF THE INVENTION

This invention generally relates to a device and method for repairing anaperture in biological tissue. More specifically, the present inventionrelates to devices and methods for deploying and attaching an implant toa biological tissue.

BACKGROUND

An object of the present invention is to provide apparatus and a methodfor performing corrective surgery on internal wounds such as herniawhere invasion of the patient's body tissues is minimized and resultanttrauma is reduced.

A hernia is a protrusion of a tissue, structure, or part of an organthrough the muscular tissue or the membrane by which it is normallycontained. In other words a hernia is a defect in the abdominal wallthrough which a portion of the intra-abdominal contents can protrude.This often causes discomfort and an unsightly, visible bulge in theabdomen. When such a hernia defect occurs in the abdominal region,conventional corrective surgery has required opening the abdominalcavity by surgical incision through the major abdominal muscles. Whilethis technique provides for effective corrective surgery of the herniadefect, it has the disadvantage of requiring a hospital stay of as muchas a week, during which pain is frequently intense, and it requires anextended period of recuperation. After the conventional surgery patientsfrequently cannot return to a full range of activity and work schedulefor a month or more. Accordingly, medical science has sought alternativetechniques that are less traumatic to the patient and provide for morerapid recovery.

Laparoscopy is the science of introducing a viewing instrument through aport into a patient's body, typically the abdominal cavity, to view itscontents. This technique has been used for diagnostic purposes for morethan 75 years. Operative laparoscopy is performed through tiny openingsin the abdominal wall called ports. In most surgical techniques severalports, frequently three to six, are used. Through one port is insertedthe viewing device, which conventionally comprises a fiber optic rod orbundle having a video camera affixed to the outer end to receive anddisplay images from inside the body. The various surgical instrumentsare inserted through other ports to do the surgery that normally wouldbe performed through an open incision through the abdominal wall.Because the laparoscopic surgical techniques require only very smallholes through the abdominal wall or other portions of the body, apatient undergoing such surgery may frequently leave the hospital withinone day after the surgery and resume a full range of normal activitieswithin a few days thereafter.

In repairing hernia the physician needs to first deploy the patch andthen to attach the patch to the tissue.

There are many patents and patent applications relating to attaching aprosthesis implant to a tissue via tacks. Each patent and patentapplication describes a different attachment mechanism via differentanchoring means (see for example U.S. Pat. No. 6,447,524). Traditionalanchors used in surgery include clips, staples, or sutures, and may alsobe referred to as tissue anchors. These devices are usually made of abiocompatible material (or are coated with a biocompatible material), sothat they can be safely implanted into the body. Most tissue anchorssecure the tissue by impaling it with one or more posts or legs that arebent or crimped to lock the tissue into position. Thus, most traditionalanchors are rigid or are inflexibly attached to the tissue. For examplePCT no. WO07/021,834 describes an anchor having two curved legs thatcross in a single turning direction to form a loop. Those two curvedlegs are adapted to penetrate tissue in a curved pathway. U.S. Pat. No.4,485,816 (refers hereinafter as 816′) describes surgical staple made ofshape memory alloy. The staple is placed in contact of the tissue andthen heated. The heating causes the staple to change its shape thus,penetrating the tissue.

U.S. Pat. No. 6,893,452 (refers hereinafter as '452) describes a tissueattachment device that facilitates wound healing by holding soft tissuetogether under improved distribution of tension and with minimaldisruption of the wound interface and its nutrient supplies. The devicehas multiple sites for grasping the tissue using tines or prongs orother generally sharp, projecting points, protruding from a single,supportive backing. One of the embodiments described in '452 is the useof sharp projecting points protruding from the supportive backing in twodifferent angles.

U.S. Pat. No. 6,517,584 (refers hereinafter as '584) describes a herniapatch which includes at least one anchoring device made of shape memorymaterial. The anchoring devices are initially secured to the prosthesisby being interlaced through a web mesh constituting the prosthesis. Theattachment is obtained by altering the attachment element's shape fromrectilinear to a loop shape due to heat induced shape memory effect.

Yet other patent literature relates to devices for endoscopicapplication of surgical staples adapted to attach surgical mesh to abody tissue.

An example of such a teaching is to be found in U.S. Pat. No. 5,364,004,U.S. Pat. No. 5,662,662, U.S. Pat. No. 5,634,584, U.S. Pat. No.5,560,224, U.S. Pat. No. 5,588,581 and in U.S. Pat. No. 5,626,587.

There are a few patent and patent applications teaching the deploymentof patches. For example U.S. Pat. No. 5,836,961 (refers hereinafter as'961) which relates to an apparatus used for developing an anatomicspace for laparoscopic hernia repair and a patch for use therewith. Theapparatus of U.S. Pat. No. '961 comprises a tubular introducer memberhaving a bore extending therethrough. A tunneling shaft is slidablymounted in the bore and has proximal and distal extremities including abullet-shaped tip. A rounded tunneling member is mounted on the distalextremity of the tunneling shaft. The apparatus comprises an inflatableballoon. Means is provided on the balloon for removably securing theballoon to the tunneling shaft. Means is also provided for forming aballoon inflation lumen for inflating the balloon. The balloon iswrapped on the tunneling shaft. A sleeve substantially encloses theballoon and is carried by the tunneling shaft. The sleeve is providedwith a weakened region extending longitudinally thereof, permitting thesleeve to be removed whereby the balloon can be unwrapped and inflatedso that it lies generally in a plane. The balloon as it is beinginflated creates forces generally perpendicular to the plane of theballoon to cause pulling apart of the tissue along a natural plane toprovide the anatomic space.

Although U.S. Pat. No. '961 relates to deploying means, U.S. Pat. No.'961 teaches a device in which the patch is attached to a balloon whichis introduced into the abdominal cavity. The deployment is performed byinflating the balloon. In other words, a totally different deployingmeans are disclosed.

Furthermore, due to the relatively large volumes of balloons severaldisadvantages are likely to occur: (a) The visibility within theabdominal cavity might be damaged; (b) The accessibility of theattachment means to the patch might be impaired; and, (c) Themaneuverability of the patch within the abdominal cavity is limited.

Yet more, another major drawback to U.S. Pat. No. '961, the inflatedballoon lacks any mechanical stiffness which is needed for navigation ofthe patch to its position.

Another example for deploying the patch can be found in U.S. Pat. No.5,370,650 (refers hereinafter as '650) which relates to an apparatus forpositioning surgical implants adjacent to body tissue to facilitate thefastening of the implant to the body tissue. U.S. Pat. No. '650 providesan apparatus for positioning surgical implants adjacent to body tissue,comprising an outer tube having a proximal end, a distal end and alongitudinal axis; an inner rod at least partially disposed within theouter tube and slidable along said longitudinal axis. The inner rod hasa proximal and a distal end portions. The inner rod distal end portionfurther comprises articulating means for pivoting at an angle withrespect to the longitudinal axis. A looped support member having firstand second end portions fixedly secured to said distal end portion ofthe inner rod; and a surgical implant releasably secured to the loopedsupport member (a preferred embodiment illustrating the teaching of U.S.Pat. No. '650 is illustrated in FIG. 17).

The major difference between U.S. Pat. No. '650 and the presentinvention is the actual patch deployment mechanism.

While in U.S. Pat. No. '650, the looped support member 14 is transferredfrom a deployed configuration to a retracted configuration by pushingand pulling tube 12, in the proposed technology the flexible arms arereconfigured from their initial stage (IS) to their final stage (FS) bythe reciprocal movement the central shaft. In other words, while in U.S.Pat. No. '650, the patch is deployed due to the elasticity of the loopmember (no force is applied), in the present application, the patch isdeployed by actively and directly applying force on the Flexible arms bythe surgeon.

Furthermore, the deployment of the patch in U.S. Pat. No. '650 ispassive and unidirectional; i.e., once the patch is deployed by pullingtube 12, the patch can not be un-deployed and reinserted into tube 12.In order to reinsert the patch into tube 12, the patch must be refoldedand such an action can not be performed while the patch is within thepatient. Therefore, the surgeon has only one chance to unfold the patch.This is in sharp contrary to the present invention in which thedeployment of the patch is bidirectional and actively controlled suchthat the patch can be deployed and un-deployed simply by thereconfiguration of the flexible arms (which a full description will beprovided in the detail description).

Yet another major distinction between U.S. Pat. No. '650 and theproposed invention is the fact that in U.S. Pat. No. '650 the loopedsupport member 14 is preferably in a deployed (i.e., open) configurationthereby insertion of the looped support member 14 into tube 12 willrequire the physician to apply a significant amount of force in order tomaintain the looped support member 14 in a closed configuration. On thecontrary, in the present invention, the flexible arms can be activelyconfigured to be constantly closed without any additional force appliedby the physician. Therefore, the insertion of the device through atrocar is facilitated.

Yet more, the present invention comprises a central shaft for providingthe device mechanical stiffness for the backbone of the system which isneeded for better positioning of the patch within the body. Further, byproviding mechanical stiffness to the backbone of the system, it willenable the detachment of the patch from the deployment system. Such amechanism is not disclosed nor claimed in U.S. Pat. No. '650.

Lastly, U.S. Pat. No. '650 describes no attachment mechanism forattaching the patch to the tissue. Further, some major, non obviousmodification will have to be made in order to enable attachment betweenthe patch and the tissue whilst using the device of U.S. Pat. No. '650.

More patent literature can be found in PCT no. WO08065653 (refershereinafter as '653) relates to a device especially adapted to deploy apatch within a body cavity. The device is an elongate open-boredapplicator (EOBP) and comprises (a) at least one inflatablecontour-balloon, (b) at least one inflatable dissection balloon. Theinflatable contour-balloon and the inflatable dissection balloon areadjustable and located at the distal portion. The EOBP additionallycomprises (c) at least one actuating means located at the proximalportion. The actuating means is in communication with the inflatablecontour-balloon and the inflatable dissection balloon. The actuatingmeans is adapted to provide the inflatable contour-balloon and theinflatable dissection balloon with independent activation and/orde-activation.

It should be pointed out that PCT '653 does not disclose nor claim meansadapted to anchor the patch to the biological tissue.

Like U.S. Pat. No. '961, the deployment system describes in PCT '653 isan inflated one, thus it is fundamentally different from the proposedinvention.

All those patent and patent application demonstrate attachment means forattaching the patch to the tissue or means for deploying the patchwithin the body. However none of the literature found relates to adevice especially adapted to deploy and attached a patch to a biologicaltissue.

Thus, there is still a long felt need for a device that can be used forboth deploying and attaching a patch to a biological tissue.

Furthermore, there is still a long felt need for a deployment systemthat will overcome the above mentioned drawbacks and will provide adeployment system that will enable the following (i) a reversibledeployment of the patch (i.e., enable the folding and the unfolding ofsaid patch); (ii) a controlled deployment of the patch (i.e., thesurgeon applies force in order to deploy the patch and therefore thedeployment is actively controlled); and, (iii) will provide mechanicalstiffness for the backbone of the system.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide an integrateddeployment and attachment device (DAD) comprising means adapted todeploy a patch and means adapted to attach said patch to a biologicaltissue within the body; wherein said DAD is adapted to sequentiallydeploy said patch within said body and attach said patch to saidbiological tissue within said body; further wherein said deployment ofsaid patch is (i) controlled such that a continuous deployment isobtained; and, (ii) bidirectional such that said deployment is fullyreversible.

It is another object of the present invention to provide the DAD asdefined above, wherein said DAD is characterized by having a distalportion, adapted to be inserted into a body and a proximal portion,located adjacent to a user; said distal portion and said proximalportion are interconnected along a main longitudinal axis via a tube(103); said tube having a proximal end (TP) connected to said proximalportion, and a distal end (TD); said tube accommodates at least aportion of a central shaft (105); said central shaft (105) has aproximal end (CSP) accommodated within said tube (103) and a distal end(CSD) protruding from said TD end; said central shaft (105) is adaptedto reciprocally move parallel to said main longitudinal axis within saidtube (103);

said distal portion comprises: (i) at least two flexible arm (FA) (104)are adapted to be reversibly coupled to said patch; said FA having aproximal end (FAP) jointly connected to said TD, and a distal end (FAD)jointly connected to said CSD; said FA (104) are characterized by havingan initial stage (IS) at which said FA (104) are straight and parallelto the longitudinal axis of said central shaft (105); and, a final stage(FS) at which said FA (104) are laterally curved with respect to saidlongitudinal axis of said central shaft (105) such that said patch isdeployed; said FA are adapted to reversibly transform from said IS tosaid FS by said reciprocate movement of said central shaft (105) towardsand away from said proximal portion such that said deployment of saidpatch is bidirectional;

said FA (104) comprises (a) at least one attachment clip (108) adaptedto attach said patch (106) to said biological tissue (501); and, (b) atleast one connecting means adapted to at least partially reversiblyconnect said patch (106) to said FA (104);

said proximal portion comprising at least one handle (102) locatedoutside said body; said handle is adapted to (i) reversibly transformsaid FA from said IS to said FS; (ii) activate said clip (108) such thatsaid patch (106) is at least partially attached to said tissue; and,(iii) release said patch from said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said connecting means are selected from at leastone dedicated loop and\or stretching means (107) or patch-FA clip (1201)adapted to reversibly connect said patch to said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said clip is adapted to attach said patch to saidbiological tissue whilst simultaneously detaching from said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said clip is adapted to first attach said patchto said biological tissue and then to detach from said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said clip is characterized by having: (i) mainportion (403) adapted to at least partially reversibly connected to saidFA; (ii) at least one hooks (402) connected to said main portion,adapted to at least partially penetrate through said patch (106) to saidtissue (501) such that an attachment between said patch and said tissueis obtained; (iii) a portion (404) adapted to reversibly connect toactivation means; said activation means are adapted to actuate saidhooks (402) such that said attachment is obtained.

It is another object of the present invention to provide the DAD asdefined above, wherein said clip additionally comprises securing means(701, 702) adapted to secure and fix said clip within said tissue andsaid patch.

It is another object of the present invention to provide the DAD asdefined above, wherein said stretching means (107) and said activationmeans are selected from a group consisting of a wire.

It is another object of the present invention to provide the DAD asdefined above, wherein said attachment between said patch and saidtissue is obtained by a radial motion of said clip followed by a linearmotion of said wire.

It is another object of the present invention to provide the DAD asdefined above, wherein said attachment between said patch and saidtissue is obtained by a linear motion of said clip followed by a linearmotion of said wire.

It is another object of the present invention to provide the DAD asdefined above, wherein said activation means is activation wire (112).

It is another object of the present invention to provide the DAD asdefined above, wherein said activation wire (112) and/or said stretchingwire 107 is made from a group consisting of biocompatible metal, shapememory materials, super elastic metals, non-degradable polymer anddegradable polymers.

It is another object of the present invention to provide the DAD asdefined above, wherein said clip is made from a group consisting ofbiocompatible metal, shape memory materials, super elastic metals,non-degradable polymer and degradable polymers.

It is another object of the present invention to provide the DAD asdefined above, especially adapted to be used in procedures selected froma group consisting of hernia surgeries, minimal invasive heartsurgeries, endoscopic colon surgeries.

It is another object of the present invention to provide the DAD asdefined above, additionally comprising a cutting mechanism adapted tocut said stretching means (107) in at least one location such that saidpatch and said FA's are detached.

It is another object of the present invention to provide the DAD asdefined above, wherein the detachment between said patch and said FA'sis obtained by means selected from a group consisting of transformingsaid FA's from said FS to said IS; mechanically moving said DAD awayfrom said patch.

It is another object of the present invention to provide the DAD asdefined above, wherein said patch-FA clips (1201) comprises a body 1202and at least one branch 1203 at least partially protruding out of saidbody; said patch-FA clip 1201 is characterized by (i) a mainlongitudinal axis along which a reciprocal motion of said body 1203 isenabled; (ii) at least two positions enabled by said reciprocal motion;a first position in which said branch 1203 is perpendicular to the patchand a second position in which said branch 1203 is parallel to saidpatch.

It is another object of the present invention to provide the DAD asdefined above, wherein said patch-FA clips (1201) comprises (i) a body1202; (ii) at least one branch 1203 coupled to said body and at leastpartially protruding out of said body; and, (iii) at least one envelopecovering (1204) at least partially covering said branch (1203); saidpatch-FA clip 1201 is characterized by at least two positions; a firstposition in which said branch 1203 is housed within said envelopecovering (1204) and perpendicular to the patch and a second position inwhich said envelope covering (1204) is removed and said branch 1203 isparallel to said patch.

It is another object of the present invention to provide the DAD asdefined above, additionally comprising means (1501 and 1502) adapted tolaterally rotate said patch with respect to said tissue, such that theright orientation of said patch is obtained.

It is another object of the present invention to provide the DAD asdefined above, additionally comprising at least one sleeve adapted to atleast partially reversibly cover said patch such that insertion of saiddistal end into said patient through a trocar is facilitated.

It is another object of the present invention to provide the DAD asdefined above, wherein said sleeve additionally comprising at least onestopper positioned at the distal end of said stopper, said stopper isadapted to prevent said sleeve from insertion into said patient.

It is another object of the present invention to provide a method fordeploying and attaching a patch to a biological tissue. The methodcomprises steps selected inter alia from:

-   -   a. obtaining a integrated deployment and attachment device        (DAD); said DAD is characterized by having a distal portion,        adapted to be inserted into a body and a proximal portion,        located adjacent to a user; said distal portion and said        proximal portion are interconnected along a main longitudinal        axis via a tube (103); said tube having a proximal end (TP)        connected to said proximal portion, and a distal end (TD); said        tube accommodates at least a portion of a central shaft (105);        said central shaft (105) has a proximal end (CSP) accommodated        within said tube (103) and a distal end (CSD) protruding from        said TD end; said central shaft (105) is adapted to reciprocally        move parallel to said main longitudinal axis within said tube        (103);        -   said distal portion comprises: (i) at least two flexible arm            (FA) (104) having a proximal end (FAP) jointly connected to            said TD, and a distal end (FAD) jointly connected to said            CSD; said FA (104) are characterized by having an initial            stage (IS) at which said FA (104) are straight and parallel            to the longitudinal axis of said central shaft (105); and, a            final stage (FS) at which said FA (104) are laterally curved            with respect to said longitudinal axis of said central shaft            (105) such that said patch is deployed; said FA are adapted            to reversibly transform from said IS to said FS by said            reciprocate movement of said central shaft (105) towards and            away from said proximal portion;        -   said FA (104) comprises (a) at least one attachment clip            (108) adapted to attach said patch (106) to said biological            tissue (501); and, (b) at least one connecting means adapted            to at least partially reversibly connect said patch (106) to            said FA (104);        -   said proximal portion comprising at least one handle (102)            located outside said body; said handle is adapted to (i)            reversibly transform said FA from said IS to said FS; (ii)            activate said clip (108) such that said patch (106) is at            least partially attached to said tissue; and, (iii) release            said patch from said FA.    -   b. introducing said distal portion into said body cavity;    -   c. reversibly transforming said FA from said IS to said FS;        thereby deploying said patch;    -   d. adjacently bringing said patch into contact with said        biological tissue;    -   e. activating said at least one clip, thereby attaching said        patch to said tissue;    -   f. detaching said at least one clip from said FA;    -   g. detaching said patch from said FA;    -   h. transforming said FA from said FS to said IS; and,    -   i. extracting said DAD from said body cavity.

It is another object of the present invention to provide the method asdefined above, wherein said step of reversibly transforming said FA fromsaid IS to said FS provides a controlled continuous deployment of saidpatch.

It is another object of the present invention to provide the method asdefined above, wherein said step of reversibly transforming said FA fromsaid IS to said FS provides a bidirectional fully reversible deployment.

It is another object of the present invention to provide the method asdefined above, wherein said steps of detaching said patch from said FAand transforming said FA from said FS to said IS are performedsimultaneously.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FA isperformed by said step of transforming said FA from said FS to said IS.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FA isperformed by mechanically moving said DAD from said patch.

It is another object of the present invention to provide the method asdefined above, wherein said steps of activating said clip and detachingsaid clip from said FA are performed simultaneously.

It is another object of the present invention to provide the method asdefined above, wherein said step of activating said clip additionallycomprising step of either linearly moving and/or radially rotating saidclip.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FAcomprising steps of cutting said connecting means at least one end; and,withdrawing said connecting means from the second end.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of selecting saidconnecting means from a group consisting of biocompatible metal, shapememory materials, super elastic metals, non-degradable polymer anddegradable polymers.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of selecting said clipfrom a group consisting of biocompatible metal, shape memory materials,super elastic metals, non-degradable polymer and degradable polymers.

It is another object of the present invention to provide the method asdefined above, additionally comprising a second step of attaching saidpatch to said biological tissue using conventional attaching means.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of reversibly attaching saidpatch to said FA.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of laterally rotating saidpatch with respect to said tissue, such that the right orientation ofsaid patch is obtained.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of at least partiallycovering said patch such that insertion of said distal end into saidpatient through a trocar is facilitated.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of preventing said sleeveadditionally form inserting into said patient by means of at least onestopper.

It is another object of the present invention to provide a clipespecially adapted to attach a patch to a biological tissue; said clipcomprises (i) at least one hook adapted to at least partially penetratethrough said patch to said biological tissue such that an attachmentbetween said patch and said tissue is obtained; (ii) a portion adaptedto at least partially reversibly connect to activation means; saidactivation means are adapted to actuate said hooks such that saidattachment is obtained;

wherein said clip is actuated and said attachment is obtained by alinear motion of said activation means.

It is another object of the present invention to provide the clip asdefined above, wherein said linear motion of said activation means isadapted to be converted into a motion selected from a group consistingof rotational motion, radial motion or linear motion of said clip; saidmotion of said clip is adapted to provide said attachment between saidpatch and said tissue via penetration of said at least one hook intosaid tissue.

It is another object of the present invention to provide the clip asdefined above, additionally comprises securing means adapted to secureand fix said clip within said tissue and said patch.

It is another object of the present invention to provide the clip asdefined above, wherein said clip is made from a group consisting ofbiocompatible metal, shape memory materials, super elastic metals,non-degradable polymer and degradable polymers.

It is another object of the present invention to provide the DAD asdefined above, wherein said DAD is characterized by having a distalportion, adapted to be inserted into a body and a proximal portion,located adjacent to a user; said distal portion and said proximalportion are interconnected along a main longitudinal axis via a tube(103); said tube having a proximal end (TP) connected to said proximalportion, and a distal end (TD); said tube accommodates at least aportion of a central shaft (105); said central shaft (105) has aproximal end (CSP) accommodated within said tube (103) and a distal end(CSD) protruding from said TD end; said central shaft (105) is adaptedto reciprocally move parallel to said main longitudinal axis within saidtube (103);

said distal portion comprises: (i) at least two flexible arm (FA) (104)having a proximal end (FAP) jointly connected to said TD, and a distalend (FAD) jointly connected to said CSD; said FA (104) are characterizedby having an initial stage (IS) at which said FA (104) are straight andparallel to the longitudinal axis of said central shaft (105); and, afinal stage (FS) at which said FA (104) are laterally curved withrespect to said longitudinal axis of said central shaft (105) such thatsaid patch is deployed; said FA are adapted to reversibly transform fromsaid IS to said FS by said reciprocate movement of said central shaft(105) towards and away from said proximal portion, such that (i) acontrolled and continuous deployment is obtained; and, (ii)bidirectional, fully reversible deployment is obtained;

said FA comprises (a) at least one connecting means adapted to at leastpartially reversibly connect said patch (106) to said FA (104);

said patch is coupled to at least one clip; said clip is adapted toattach said patch (106) to said biological tissue (501);

said proximal portion comprising at least one handle (102) locatedoutside said body; said handle is adapted to (i) reversibly transformsaid FA from said IS to said FS; (ii) activate said clip (108) such thatsaid patch (106) is at least partially attached to said tissue; and,(iii) release said patch from said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said connecting means are selected from at leastone dedicated loop and stretching means (107) or patch-FA clip 1201adapted to reversibly connect said patch to said FA.

It is another object of the present invention to provide the DAD asdefined above, wherein said patch-FA clips 1201 comprises a body 1202and at least one branch 1203 at least partially protruding out of saidbody; said patch-FA clip 1201 is characterized by (i) a mainlongitudinal axis along which a reciprocal motion of said body 1203 isenabled; (ii) at least two positions enabled by said reciprocal motion;a first position in which said branch 1203 is perpendicular to the patchand a second position in which said branch 1203 is parallel to saidpatch.

It is another object of the present invention to provide the DAD asdefined above, wherein said patch-FA clips (1201) comprises (i) a body1202; (ii) at least one branch 1203 coupled to said body and at leastpartially protruding out of said body; and, (iii) at least one envelopecovering (1204) at least partially covering said branch (1203); saidpatch-FA clip 1201 is characterized by at least two positions; a firstposition in which said branch 1203 is housed within said envelopecovering (1204) and perpendicular to the patch and a second position inwhich said envelope covering (1204) is removed and said branch 1203 isparallel to said patch.

It is another object of the present invention to provide a patchespecially adapted to be connected to a biological tissue; wherein saidpatch is connected to at least one clip adapted to attache said patch tosaid biological tissue.

It is another object of the present invention to provide a deploymentdevice (DD) adapted to deploy a patch within a body cavity; wherein saidDD is characterize by having a distal portion, adapted to be insertedinto a body and a proximal portion, located adjacent to a user; saiddistal portion and said proximal portion are interconnected along a mainlongitudinal axis via a tube (103); said tube having a proximal end (TP)connected to said proximal portion, and a distal end (TD); said tubeaccommodates at least a portion of a central shaft (105); said centralshaft (105) has a proximal end (CSP) accommodated within said tube (103)and a distal end (CSD) protruding from said TD end; said central shaft(105) is adapted to reciprocally move parallel to said main longitudinalaxis within said tube (103);

said distal portion comprises: (i) at least two flexible arm (FA) (104)are adapted to be reversibly coupled to said patch; said FA having aproximal end (FAP) jointly connected to said TD, and a distal end (FAD)jointly connected to said CSD; said FA (104) are characterized by havingan initial stage (IS) at which said FA (104) are straight and parallelto the longitudinal axis of said central shaft (105); and, a final stage(FS) at which said FA (104) are laterally curved with respect to saidlongitudinal axis of said central shaft (105) such that said patch isdeployed; said FA are adapted to reversibly transform from said IS tosaid FS by said reciprocate movement of said central shaft (105) towardsand away from said proximal portion;

said FA comprises at least one connecting means adapted to at leastpartially reversibly connect said patch (106) to said FA (104);

said proximal portion comprising at least one handle (102) locatedoutside said body; said handle is adapted to (i) reversibly transformsaid FA from said IS to said FS; and, (ii) release said patch from saidFA;

wherein said deployment of said patch is (i) controlled such that acontinuous deployment is obtained; and, (ii) bidirectional such thatsaid deployment is fully reversible.

It is another object of the present invention to provide the DD asdefined above, wherein said connecting means are selected from at leastone dedicated loop and stretching means (107) or patch-FA clip 1201adapted to reversibly connect said patch to said FA.

It is another object of the present invention to provide the DD asdefined above, wherein said patch-FA clips 1201 comprises a body 1202and at least one branch 1203 at least partially protruding out of saidbody; said patch-FA clip 1201 is characterized by (i) a mainlongitudinal axis along which a reciprocal motion of said body 1203 isenabled; (ii) at least two positions enabled by said reciprocal motion;a first position in which said branch 1203 is perpendicular to the patchand a second position in which said branch 1203 is parallel to saidpatch.

It is another object of the present invention to provide the DD asdefined above, wherein said patch-FA clips (1201) comprises (i) a body1202; (ii) at least one branch 1203 coupled to said body and at leastpartially protruding out of said body; and, (iii) at least one envelopecovering (1204) at least partially covering said branch (1203); saidpatch-FA clip 1201 is characterized by at least two positions; a firstposition in which said branch 1203 is housed within said envelopecovering (1204) and perpendicular to the patch and a second position inwhich said envelope covering (1204) is removed and said branch 1203 isparallel to said patch.

It is another object of the present invention to provide the DD asdefined above, wherein said stretching means are selected from a groupconsisting of a wire.

It is another object of the present invention to provide the DD asdefined above, wherein said stretching wire 107 is made from a groupconsisting of biocompatible metal, shape memory materials, super elasticmetals, non-degradable polymer and degradable polymers.

It is another object of the present invention to provide the DD asdefined above, additionally comprising a cutting mechanism adapted tocut said stretching means (107) such that said patch and said FA's aredetached.

It is another object of the present invention to provide the DD asdefined above, wherein the detachment between said patch and said FA'sis obtained by means selected from a group consisting of transformingsaid FA's from said FS to said IS; mechanically moving said DAD awayfrom said patch.

It is another object of the present invention to provide the DD asdefined above, especially adapted to hernia surgeries.

It is another object of the present invention to provide the DD asdefined above, additionally comprising means (1501 and 1502) adapted tolaterally rotate said patch with respect to said tissue, such that theright orientation of said patch is obtained.

It is another object of the present invention to provide the DD asdefined above, additionally comprising at least one sleeve at leastpartially covering said patch such that insertion of said distal endinto said patient through a trocar is facilitated.

It is another object of the present invention to provide the DD asdefined above, wherein said sleeve additionally comprising a stopperpositioned at the distal end of said stopper, said stopper is adapted toprevent said sleeve from insertion into said patient.

It is another object of the present invention to provide a method fordeploying within a body cavity. The method comprises steps selectedinter alia from:

-   -   a. obtaining a deployment device characterize by having a distal        portion, adapted to be inserted into a body and a proximal        portion, located adjacent to a user; said distal portion and        said proximal portion are interconnected along a main        longitudinal axis via a tube (103); said tube having a proximal        end (TP) connected to said proximal portion, and a distal end        (TD); said tube accommodates at least a portion of a central        shaft (105); said central shaft (105) has a proximal end (CSP)        accommodated within said tube (103) and a distal end (CSD)        protruding from said TD end; said central shaft (105) is adapted        to reciprocally move parallel to said main longitudinal axis        within said tube (103);        -   said distal portion comprises: (i) at least two flexible arm            (FA) (104) having a proximal end (FAP) jointly connected to            said TD, and a distal end (FAD) jointly connected to said            CSD; said FA (104) are characterized by having an initial            stage (IS) at which said FA (104) are straight and parallel            to the longitudinal axis of said central shaft (105); and, a            final stage (FS) at which said FA (104) are laterally curved            with respect to said longitudinal axis of said central shaft            (105) such that said patch is deployed; said FA are adapted            to reversibly transform from said IS to said FS by said            reciprocate movement of said central shaft (105) towards and            away from said proximal portion;        -   said FA comprises at least one connecting means adapted to            at least partially reversibly connect said patch (106) to            said FA (104);        -   said proximal portion comprising at least one handle (102)            located outside said body; said handle is adapted to (i)            reversibly transform said FA from said IS to said FS;            and, (ii) release said patch from said FA;    -   b. inserting said distal portion into said body cavity;    -   c. reversibly transforming said FA from said IS to said FS;        thereby deploying said patch;    -   d. detaching said patch from said FA;    -   e. transforming said FA from said FS to said IS; and,    -   f. extracting said DAD from said body cavity.

It is another object of the present invention to provide the method asdefined above, wherein said step of reversibly transforming said FA fromsaid IS to said FS provides a controlled continuous deployment of saidpatch.

It is another object of the present invention to provide the method asdefined above, wherein said step of reversibly transforming said FA fromsaid IS to said FS provides a bidirectional fully reversible deployment.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FAcomprising steps of cutting said connecting means in at least one end;and, withdrawing said connecting means from the second end.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of selecting saidconnecting means from a group consisting of biocompatible metal, shapememory materials, super elastic metals, non-degradable polymer anddegradable polymers.

It is another object of the present invention to provide the method asdefined above, additionally comprising a second step of attaching saidpatch to said biological tissue using conventional attaching means.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of reversibly attaching saidpatch to said FA.

It is another object of the present invention to provide the method asdefined above, wherein said steps of detaching said patch from said FAand transforming said FA from said FS to said IS are performedsimultaneously.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FA isperformed by said step of transforming said FA from said FS to said IS.

It is another object of the present invention to provide the method asdefined above, wherein said step of detaching said patch from said FA isperformed by mechanically moving said DAD from said patch.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of laterally rotating saidpatch with respect to said tissue, such that the right orientation ofsaid patch is obtained.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of at least partiallycovering said patch such that insertion of said distal end into saidpatient through a trocar is facilitated.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of preventing said sleevefrom inserting into said patient by means of at least one stopper.

It is another object of the present invention to provide a deploymentdevice (DD) adapted to deploy a patch within a body cavity; wherein saidDD is characterize by having a distal portion, adapted to be insertedinto a body and a proximal portion, located adjacent to a user; saiddistal portion and said proximal portion are interconnected along a mainlongitudinal axis via a tube (103); said tube having a proximal end (TP)connected to said proximal portion, and a distal end (TD); said tubeaccommodates at least a portion of a central shaft (105); said centralshaft (105) has a proximal end (CSP) accommodated within said tube (103)and a distal end (CSD) protruding from said TD end; said central shaft(105) is adapted to reciprocally move parallel to said main longitudinalaxis within said tube (103);

said distal portion comprises: (i) at least two flexible arm (FA) (104)having a proximal end (FAP) jointly connected to said TD, and a distalend (FAD) jointly connected to said CSD; each of said FA (104) comprisesat least two portions jointly coupled together; said FA (104) arecharacterized by having an initial stage (IS) at which said FA (104) arestraight and parallel to the longitudinal axis of said central shaft(105); and, a final stage (FS) at which said FA (104) are perpendicularwith respect to said longitudinal axis of said central shaft (105); saidFA are adapted to reversibly transform from said IS to said FS by saidreciprocate movement of said central shaft (105) and via said jointtowards and away from said proximal portion;

said FA comprises at least one extension (1801) comprises at least oneconnecting means adapted to at least partially reversibly connect saidpatch (106) to said extension (1801);

said proximal portion comprising at least one handle (102) locatedoutside said body; said handle is adapted to (i) reversibly transformsaid FA from said IS to said FS; and, (ii) release said patch from saidFA;

wherein said deployment of said patch is (i) controlled such that acontinuous deployment is obtained; and, (ii) bidirectional such thatsaid deployment is fully reversible.

It is another object of the present invention to provide the DD asdefined above, wherein said connecting means are selected from at leastone dedicated loop and stretching means (107) or patch-FA clip 1201adapted to reversibly connect said patch to said FA.

It is another object of the present invention to provide the DD asdefined above, wherein said patch-FA clips 1201 comprises a body 1202and at least one branch 1203 at least partially protruding out of saidbody; said patch-FA clip 1201 is characterized by (i) a mainlongitudinal axis along which a reciprocal motion of said body 1203 isenabled; (ii) at least two positions enabled by said reciprocal motion;a first position in which said branch 1203 is perpendicular to the patchand a second position in which said branch 1203 is parallel to saidpatch.

It is another object of the present invention to provide the DD asdefined above, wherein said patch-FA clips (1201) comprises (i) a body1202; (ii) at least one branch 1203 coupled to said body and at leastpartially protruding out of said body; and, (iii) at least one envelopecovering (1204) at least partially covering said branch (1203); saidpatch-FA clip 1201 is characterized by at least two positions; a firstposition in which said branch 1203 is housed within said envelopecovering (1204) and perpendicular to the patch and a second position inwhich said envelope covering (1204) is removed and said branch 1203 isparallel to said patch.

It is another object of the present invention to provide the DD asdefined above, wherein said stretching means are selected from a groupconsisting of a wire.

It is another object of the present invention to provide the DD asdefined above, wherein said stretching wire 107 is made from a groupconsisting of biocompatible metal, shape memory materials, super elasticmetals, non-degradable polymer and degradable polymers.

It is another object of the present invention to provide the DD asdefined above, wherein the detachment between said patch and said FA'sis obtained by means selected from a group consisting of transformingsaid FA's from said FS to said IS; mechanically moving said DAD awayfrom said patch.

It is another object of the present invention to provide the DD asdefined above, especially adapted to hernia surgeries.

It is another object of the present invention to provide the DD asdefined above, additionally comprising means (1501 and 1502) adapted tolaterally rotate said patch with respect to said tissue, such that theright orientation of said patch is obtained.

It is still an object of the present invention to provide the DD asdefined above, additionally comprising at least one sleeve at leastpartially covering said patch such that insertion of said distal endinto said patient through a trocar is facilitated.

It is lastly an object of the present invention to provide the DD asdefined above, wherein said sleeve additionally comprising a stopperpositioned at the distal end of said stopper, said stopper is adapted toprevent said sleeve from insertion into said patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIGS. 1 a and 1 b is a schematic diagram showing a device which is apreferred embodiment of the present invention.

FIGS. 2A-2D which illustrate the patch deployment process.

FIGS. 2E-2F represent a side view of the distal portion of device 100once the patch is deployed.

FIGS. 2G-2I illustrate the distal portion 101 of device 100 in a 3Dconfiguration.

FIGS. 3A-3C illustrate a number of options for the folding of patch 106prior to inserting the distal end 101 to the body.

FIGS. 4A-4B illustrate one possible option for the attachment clips.

FIGS. 5A-5D illustrate the attachment between a patch 106 and a tissue501.

FIGS. 6A-6F illustrate means adapted to reversibly connect clips 108 tothe FAs 104.

FIGS. 7A-7B illustrate the clip 108 according to another preferredembodiment of the present invention.

FIGS. 7C-7N illustrate another embodiments of clips 108. Said clip 108are activated by pulling.

FIGS. 8A-8F illustrate several embodiments for the connection betweenthe activation wire 112 and the clip 108.

FIGS. 9A-9D represent a cross sectional view of the mechanism 901 forcutting the activation wire 112 and the stretching wire 107.

FIGS. 10A-10E represent the proximal portion 102 in different stages ofthe deployment and the attachment.

FIGS. 11 and 12A-12G illustrate different coupling (connecting) meansbetween the patch 106 and the FAs 104 (i.e., the patch-FA clips 1201).

FIGS. 12H-12J illustrate an approach of mounting the patch 106 on thedeployment system (i.e., another embodiment to the patch-FA clips 1201).

FIGS. 12K-12Q illustrate another approach of mounting the patch 106 onthe deployment system (i.e., another embodiment to the patch-FA clips1201).

FIGS. 13A-13F illustrate an alternative embodiment for attaching patch106 to the tissue 501 by several clips 108.

FIGS. 14A-14D illustrate an alternative detachment mechanism between thepatch 106 and the FAs 104.

FIGS. 15A-15D, illustrate the controllable/flexible joint 103.

FIGS. 16A-16C illustrate the patch insertion sleeve.

FIG. 17 illustrates a deployment system according to prior art.

FIGS. 18A-18D illustrates another preferred embodiment of the deploymentsystem.

DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of the invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications, however,is adapted to remain apparent to those skilled in the art, since thegeneric principles of the present invention have been definedspecifically to provides a device and method for deploying and attachinga patch to a biological tissue.

The present provides a deployment and attachment device (DAD) whereinthe DAD is adapted to both deploy a patch within the body and to attachthe patch to a biological tissue within the body.

It should be emphasized that the DAD is adapted to sequentially deploysaid patch within said body and attach said patch to said biologicaltissue within said body, such that the deployment of said patch is (i)controlled so as a continuous deployment is obtained; and, (ii)bidirectional so as said deployment is fully reversible.

The present invention also provides a method for deploying and attachinga patch to a biological tissue. The method comprises steps selectedinter alia from:

-   -   a. obtaining a DAD;    -   b. inserting the distal portion into the body cavity;    -   c. reversibly transforming the FA from the IS to the FS; thereby        deploying the patch;    -   d. adjacently bringing the patch into contact with the        biological tissue;    -   e. activating the clip, thereby attaching the patch to the        tissue;    -   f. detaching the clip from the FA;    -   g. detaching the patch from the FA;    -   h. transforming the FA from the FS to the IS;    -   i. extracting the DAD from the body cavity.

The present invention additionally provides a clip especially adapted toattach a patch to a biological tissue; the clip comprises (i) at leastone hook adapted to at least partially penetrate through the patch tothe biological tissue such that an attachment between the patch and thetissue is obtained; (ii) a portion adapted to reversibly connectactivation means; the activation means are adapted to actuate the hookssuch that the attachment is obtained. The clip is actuated and theattachment is obtained by a linear motion of the activation means.

Still the present invention provides a deployment device (DD) adapted todeploy a patch within a body cavity; wherein the DD is characterize byhaving a distal portion, adapted to be inserted into a body and aproximal portion, located adjacent to a user. The distal portion and theproximal portion are interconnected along a main longitudinal axis via atube; the tube having a proximal end (TP) connected to the proximalportion, and a distal end (TD); the tube accommodates at least a portionof a central shaft; the central shaft has a proximal end (CSP)accommodated within the tube and a distal end (CSD) protruding from theTD end; the central shaft is adapted to reciprocally move parallel tothe main longitudinal axis within the tube. The distal portioncomprises: (i) at least two flexible arm (FA) having a proximal end(FAP) connected via a joint to the TD, and a distal end (FAD) connectedvia a joint to the CSD; the FA are characterized by having an initialstage (IS) at which the FA are straight and parallel to the longitudinalaxis of the central shaft; and, a final stage (FS) at which the FA arelaterally curved with respect to the longitudinal axis of the centralshaft such that the patch is deployed; the FA are adapted to reversiblytransform from the IS to the FS by the reciprocate movement of thecentral shaft towards and away from the proximal portion. The FAcomprises (a) at least one dedicated loop and stretching means adaptedto reversibly connect the patch to the FA. The proximal portioncomprising at least one handle located outside the body; the handlesadapted to (i) reversibly transform the FA from the IS to the FS; and,(ii) release the patch from the FA.

Yet it is an object of the present invention to provide a method fordeploying within a body cavity. The method comprises steps selectedinter alia from:

-   -   a. obtaining a DD as defined above;    -   b. inserting the distal portion into the body cavity;    -   c. reversibly transforming the FA from the IS to the FS; thereby        deploying the patch;    -   d. detaching the patch from the FA;    -   e. transforming the FA from the FS to the IS; and,    -   f. extracting the DAD from the body cavity.

It should be emphasized that some of the major advantages of the presentinvention, with respect to the prior art, is to provide a deploymentsystem or a deployment and attachment system that enables (a) anactively deployment—the deployment is actively controlled by the surgeon(as opposed to passive deployment); (b) the deployment is continuous(analogous and not binary such that several deployment levels can beobtained); and, (c) the deployment is bidirectional such that it can befully reversible.

The term ‘close form’ or ‘initial stage’ refers hereinafter to the stateof the flexible side arms FA in their initial stage as can be seen fromFIG. 2A.

The term ‘open form’ or ‘final stage’ refers hereinafter to the state ofthe flexible side arms in their final stage as can be seen from FIG. 2Cor 2D.

The term ‘bidirectional’ or ‘fully reversible deployment’ refershereinafter to the deployment of the patch, which according to thepresent invention, is fully reversible. In other words, the patchdeployment is bidirectional, i.e., the patch can be fully folded (i.e.,deployed within the body) and then, if the surgeon desires, the patchcan be fully unfolded simply by the reconfiguration of the flexible armsfrom the initial stage to the final stage and vice versa.

The term ‘controlled deployment’ refers hereinafter to a patchdeployment which is continuous; i.e., the deployment is not binary butanalogous—there are several deployment levels. This is in contrast soconventional deployment system is now days (see for example U.S. Pat.No. 5,370,650, FIG. 17), in which the deployment of the patch reliesupon the elasticity of a loop member surrounding the patch such that thepatch can be either fully folded or fully unfolded. No intermediate areenabled. In the present invention there can be several deploymentstages.

The term ‘aneurysm’ refers hereinafter to an aneurysm (or aneurism) is alocalized, blood-filled dilation (balloon-like bulge) of a blood vesselcaused by disease or weakening of the vessel wall.

The term ‘Photolithography’ or ‘photochemical lithography’ refershereinafter to a process used in microfabrication to selectively removeparts of a thin film (or the bulk of a substrate). It uses light totransfer a geometric pattern from a photomask to a light-sensitivechemical (photoresist, or simply “resist”) on the substrate. A series ofchemical treatments then engraves the exposure pattern into the materialunderneath the photoresist.

The term ‘laser cutting’ refers hereinafter to a technology that uses alaser to cut materials.

The term “Biocompatible materials” refers hereinafter to materials thathave the ability to perform with an appropriate host response in aspecific application. Biocompatible materials have the quality of nothaving toxic or injurious effects on biological systems.

The term “self-dissolving materials” or “biodegradable materials” refershereinafter to materials that are degraded by the body's enzymaticpathways through a reaction against “foreign” material. Some urologistsmay prefer self-dissolving materials in catheter simply because thenthey don't have to go necessarily through the procedure of removing themafterwards. Examples of self-dissolving polymers are Polydioxanone(PDO), Polycaprolactone (PCL), Polylactic acid (PLA), Polyglycolic acid(PGA), Adipic acid, PEG and glutamic acid

The term “shape memory materials” refers hereinafter to materials whichcan “remember” there original geometry. After a sample of shape memorymaterials has been deformed from its original geometry, it regains itsoriginal geometry by itself during heating (one-way effect) or, athigher ambient temperatures, simply during unloading (pseudo-elasticityor superelasticity). The thermally induced shape-memory effect has beendescribed for different material classes: polymers, such aspolyurethanes, poly(styrene-block-butadiene), Polydioxanone andpolynorbornene, metallic alloys, such as copper-zinc-aluminium-nickel,copper-aluminium-nickel, and nickel-titanium (NiTi) alloys.

The term “Hernia” refers hereinafter for umbilical hernia, hiatalhernia, ventral hernia, postoperative hernia, epigastric hernia,spiegelian hernia, inguinal hernia and femoral hernia, generally anyabdominal wall related hernia.

The term “orientation of the patch” refers hereinafter to the ability tolaterally rotate the patch within the abdominal cavity. Since the shapeof the patch is not symmetrical (i.e., rectangular or i.e., ellipse)—ithas different directions. Therefore it is highly important to orient thepatch (i.e., laterally rotate it) so as the right direction/orientationwill face the tissue/hernia.

The term “minimally invasive surgery” refers hereinafter to proceduresthat avoid open invasive surgery in favor of closed or local surgerywith fewer traumas. Furthermore, the term refers to a procedure that iscarried out by entering the body through the skin or through a bodycavity or anatomical opening, but with the smallest damage possible.

Before explaining the figures, it should be understood that theinvention is not limited in its application to the details ofconstruction and the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The invention canbe carried out in various ways.

Reference is now made to FIGS. 1 a and 1 b which describes a preferredembodiment of the present invention.

FIG. 1 a is a general view of the deployment and attachment device andFIG. 1 b is a closer view of a portion of said deployment and attachmentdevice. According to that embodiment a device 100 which is adapted fordeployment and attachment of prosthetic mesh during a minimal invasive(Laparoscopic) hernia repair surgery is provided. The deployment andattachment device (DAD) 100 comprises 2 main portions: distal portion101, and a proximal portion 102. The distal portion is adapted to beinserted into a body during the surgery via a trocar. The distal portionis also adapted to deploy and attach a hernia patch to the patient'stissue surface. The proximal portion 102 comprises a handle 113 whichprovides the surgeon with the ability to control the deployment andattachment of the patch. The two portions are connected via a tube 103.

The distal portion comprises of at least 2 flexible side arms (FA) 104adapted to be bended laterally. The FA are connected at their distal endto the distal end of a central flexible shaft 105, and at their proximalend to the distal end of the tube 103, the connection is made using aflexible joint. The central flexible shaft 105 is adapted toreciprocally move within the tube 103 thereby spread and deploy thepatch 106.

A prosthetic hernia repair patch 106 is folded in between the flexiblearms (FA) 104 and connected to them via stretching means or especially awire 107 which passes through the patch and a plurality of dedicatedloops 110 located on the FAs 104. The two ends of the wire are connectedto the proximal portion 102. A plurality of dedicated hernia clips 108are connected to the FA 104 at special connection points 111. Sais clips108 are adapted to attach the patch 106 to the tissue. All the clips 108are connected together by at least one wire (activation wire) 112 whichwill serve as their activation means. One end of the activation wire 112is connected to the proximal portion 102.

The patch 106 is initially coupled to the FAs by a stretching wire 107and is folded in between the FAs 104 such that it can be inserted intothe body within a trocar 114. Once the patch is inserted it is deployedby the central shaft 105 and the FAs 104. Next, the physician brings thepatch into adjacent contact with the tissue. Then, the patch is attachedto the tissue by clips 108 which are activated by the activation wire112. Once the patch is attached to the tissue the activation wire 112and the stretching wire 107 are cut via a dedicated cutting mechanismpositioned in the distal end of tube 103. Next, the stretching wire ispulled towards the proximal portion and extracted. By doing so, thepatch is no longer coupled to the FAs 104. Next, the FAs brought backinto their initial stage, which enables their extraction from the bodythrough the trocar 114.

Reference is now made to FIGS. 2A-2D which illustrate the patchdeployment process. The initial stage is described in FIG. 2A at whichthe two FAs are parallel and straight (‘close form’). Furthermore, thepatch 106 is folded in between the two FAs (FIG. 2A). Once the distalportion has been inserted into the abdominal cavity, the physiciandeploys the patch by pressing the handle 113 (see FIG. 1, 10A-10E) atthe proximal portion 102. Pressing handle 113 results in a movement ofthe central shaft 105 toward the proximal portion 102. As a result, thedistance between the distal end of the central shaft 105 and the distalend of the tube 103 become shorter. Since the FAs 104 are connected tothe distal end of the central shaft and the distal end of the tube 10;and since the distance becomes shortened the FAs buckle and bendlaterally, thereby forming an eye shape loop as described at FIG. 2B. Atthis point, the two FAs are in their final stage (‘open form’). Itshould be pointed out that, whilst the FAs 104 are bended, a continuestension at the stretching wire 107 is maintained. The continues tensionresults in the deployment of the patch 106 together with the bending ofthe FAs 104. Once the FAs 104 reach their final stage, the patch 106 iscompletely unfolded and deployed (FIG. 2C). At this point the physicianbrings the patch to be in contact with the tissue and attaches the patchin a way which will be discus further on. Once the patch have beenattached to the tissue, the physician detaches it from the FAs 104 byreleasing one end of the stretching wire 107 and pulling it toward theproximal portion 102 (FIG. 2D).

It should be pointed out that the FAs 104 are flexible in the lateraldirection and very stiff on the perpendicular direction such that onapplied pressure (by the central shaft) they buckle only laterally.Furthermore, due to the fact that the FAs are very stiff on theperpendicular direction, the applied pressure by the central shaft willbe equally distributed along the FAs. If the pressure was not equallydistributed and was concentrated only at the edges (close to the centralshaft), the central portion of the FAs would not be able to applysufficient pressure on the tissue to enable an attachment.

Reference is now made to FIGS. 2E-2F which illustrate a side view of thedistal portion of device 100 once the patch is deployed. As can be seenfrom the figures the device 100 will be able to adjust itself underpressure applied by the physician so as to bring the patch 106 into fullcontact with the tissue 501. This is due to the fact that the centralshaft 105 is flexible. Another option for this capability of device 100(to be adjustable) is to locate a joint 220 between the distal end oftube 103 and the proximal end of the FA's 104.

Reference is now made to FIGS. 2G-2I which illustrate the distal portion101 of device 100 adapted to deploy and attach a patch onto a curvedsurface, i.e. 3D configuration. The 3D device additionally comprises atleast one flexible arm 221 in a 3D configuration. The FIG. 2G representthe 3D device in which the FAs 221 and 104 are in a close configuration(initial stage) and FIG. 2H represent the FAs 221 and 104 in the openconfiguration (final stage). FIG. 2I represents the 3D device with thepatch 106. Deploying and attaching the patch will be done essentiallythe same as for the 2D device.

FIG. 3 describes a number of options for the folding of patch 106 priorto inserting the distal end 101 to the body. In all of the drawings afront cross section is seen showing the patch 106, the FA 104, the clip108 and the trocar 114. FIG. 3A describes the most simple form offolding the patch 106. As can be seen from the figure, the patch 106 isfolded between the two FA 104 in a zigzag form. The main advantage ofthis form is the fact that this fold is reversible. I.e. it is mostlikely that the patch will return to this form of folding from anunfolded state when FAs return to their close form. This enables a fastand easy extraction from the body in case the patch was not attached tothe tissue.

FIG. 3B describes the most efficient fold. This folding enable to uselargest patch since it exploits and utilizes almost the entire availablespace in the trocar 114. Another advantage of this folding it the factthe patch is located above the clips 108 when it is in the unfoldedstage, reducing the risk of entanglement between the patch 106 and theclips 108.

FIG. 3C describes a variation of the previous patch folding. Thisfolding is simpler to implement and it also have the advantage ofreducing the entanglement risk as mentioned before.

Reference is now made to FIGS. 4A-4B which illustrate the attachmentclips and their use during the attachment process.

FIGS. 4A-4B describe a preferred embodiment of the clip 108. The clipcomprises of a main portion 401 which is connected to at least 2 lateralcurved hooks 402 adapted to penetrate the tissue. The main portion isreversibly connected to the FAs 104 by a central connection area 403.The clip 108 additionally comprises a connection point 404 to theactivation wire 112. In a preferred embodiment of the present inventionthe connection point 404 is positioned laterally to the main portion401. It should be pointed out that the activation wire 112 connects allthe clips 108 together. Furthermore, as can be seen from FIG. 4A the twohooks 402 are titled with regards to the main portion 401. This inclineis of much importance. This incline is responsible for the fact that thehooks' edges 410 are constantly presses against the tissue prior to theclip's activation; such that once the clips are activated, the edges410, will penetrate the tissue and not only slide along the patch 106surface.

The clip 108 can be made of any biocompatible metal (such as stainlesssteel, titanium), shape memory materials, super elastic metals (such asNitinol i.e. NiTi), non-degradable polymer (such as polyurethane, PVC,PTFE (i.e. Teflon), PC (polycarbonate), degradable polymers (such asPLA, PGA, PLLA, PCL, PDS).

It should be pointed out that the clips 108 can be produced byphotochemical lithography methods, laser cutting method.

The FA can be made of any biocompatible metal (such as stainless steel,titanium), shape memory materials, super elastic metals (such as Nitinoli.e. NiTi), non-degradable polymer (such as polyurethane, PVC, PTFE(i.e. Teflon), PC (polycarbonate).

The activation wire 112 and the stretching wire 107 can be made of anybiocompatible metal (such as stainless steel, titanium), shape memorymaterials, super elastic metals (such as Nitinol i.e. NiTi),non-degradable polymer (such as polyurethane, PVC, PTFE (i.e. Teflon),PC (polycarbonate), degradable polymers (such as PLA, PGA, PLLA, PCL,PDS).

Reference is now made to FIGS. 5A-5D which describes the attachmentbetween a patch 106 and a tissue 501. FIG. 5A illustrates the tissue501, the patch 106, the clips 108, the FAs 104 and the activation wire112. Once the physician brings the patch adjacent and in contact withthe tissue (FIG. 5B), the activation wire 112 is then pulled, generatinga rotational moment which rotates the clip with regards to the FAs 104.The rotational movement inserts the hooks 402 into the tissue 501through the patch 106, thereby providing a strong attachment between thepatch 106 and the tissue 501 (FIG. 5C). The connection between the clip108 and the FAs 104 is made in such a way that the clips 108 are securedto the FAs 104 prior to the attachment; and, the clips 108 detach fromthe FAs 104 once they are attached to the tissue 501 (FIG. 5D).

Reference is now made to FIGS. 6A-6C which illustrate means adapted toreversibly connect clips 108 to the FAs 104. According to thisembodiment, clips 108 are connected to the FA's by hooks. As can be seenfrom the FIG. 6A the hooks 601 protrude from the FA's into portion 403of the clip 108. The clips are secured to the FA's due to L shape ofhook 601.

Two niches 602 are located on two opposite side along portion 403perimeter. Prior to activating the clips (i.e. pulling activation wire112), the niches 602 are not aligned together with the hooks 601. Oncethe clips are activated, or in other words they rotate, the hooks 601are aligned with the niches 602 (see FIG. 6B) such that the attachmentbetween the clips and the FA is cancelled and the clips 108 are releasedfrom the FA 104 (see FIG. 6C).

Reference is now made to FIGS. 6D-6F which illustrate means according toanother embodiment adapted to reversibly connect clips 108 to the FAs104. According to this embodiment, clips 108 are connected to the FA'sby a dedicated screw. As can be seen from FIG. 6D, screw 603 protrudefrom the FA's into portion 403 of the clip 108. The clips are screwedinto screw 603 thereby secured to the FA's.

The clips can be detached from the FAs by screwing out the clips fromscrew 603 (see FIG. 6E). Once the clips 108 are screwed out from thescrew 603 they are released from the FAs (see FIG. 6F).

It should be pointed that it is in the scope of the present inventionwherein the clips 108 can be attached to the tissue and detach from theFA simultaneously or it can be done in two different steps.

Reference is now made to FIGS. 7A-7B which illustrate the clip 108according to another preferred embodiment of the present invention.According to this embodiment, the clip 108 includes at least oneadditional hook 701 located on the lateral hooks 402. This hook 701 isadapted to prevent the reverse rotation (hence the release) of the clip108 from the tissue 501. It is acknowledged that the attachment betweenthe patch 106 and the tissue 501 can be annulled if the clip 106 rotatesin the reverse rotational motion when subjected to external loads.Therefore, the additional hook 701 prevents this reverse rotationalmotion with minimal interference to the forward rotation. Clip 108 mayadditionally comprise at least one hook 702 which is adapted to preventany unwanted movement between the patch 106 and the clip 108.

It is in the scope of the present invention wherein attachment clips,activated by pulling, are provided. Another example for such clips isdemonstrated in FIGS. 7C-7H. FIG. 7C illustrates an arrow-like clip 108.The Clip 108 is characterized by having a plate 711 and an arrow-likeshaped hook 712. Hook 712 is adapted to penetrate the patch 106 and thetissue 501. Plate 711 also comprises groove cut 713 and a dedicatedaperture 714. As described before, clip 108 has a connection point 403to the activation wire 112.

FIGS. 7D-7G illustrate the steps needed for attaching the clip to thetissue 501.

FIG. 7D illustrates the clip 108 coupled to the FA 104 and being broughtinto adjacent contact with the tissue 501. FIG. 7E illustrates the clip108 being presets against the tissue 501. The next step is attaching thepatch to the tissue via clips 108 (FIG. 7F). The attachment is obtainedby pulling the activation wire 112. Once the clip 108 is attached to thetissue 501, it detaches from the FA 104 (FIG. 7G).

FIGS. 7H-7J illustrate a closer view of the arrow-like clip 108 and howit detaches from the FAs 104.

FIG. 7H illustrate the clip 108 attached to the FAs 104. The attachmentbetween the clip 108 and the FA is provided by a dedicated hook 715which is inserted into the groove cut 713 in the plate 711.

When the activation wire 112 is pulled (by the handle 1002) the clips108 are pulled towards the proximal portion 102. By pulling the clips108, the arrow like hook 712 penetrates the tissue 501. The result ofthis pulling is the movement of hook 715 within the groove cut 713 untilsaid hook 715 reaches the dedicated aperture 714. Aperture 714 isadapted to fit the dimensions, shape and size of the hook 715. Once hook715 reaches the aperture 714 (FIG. 7I) the clip 108 can be detach fromthe FA 104 (FIG. 7J).

FIGS. 7K-7N illustrate a clip 108 according to another embodiment of thepresent invention. This clip 108 is characterized by a plate 711 and asharp curved edge 720. Plate 711 is attached to the FAs 104 by a screwor by a pin 721 (see FIG. 7N). Pin 721 is adapted to be reversiblyconnected to a dedicated connection area 730 within clip 108. Asdescribed before, clip 108 has a connection point 403 which is adaptedto be connected to the activation wire 112.

FIGS. 7L-7—illustrate the steps needed for attaching the clip to thetissue 501.

FIG. 7L illustrate the clip 108 attached to the FAs 104 and beingbrought into adjacent contact with the tissue 501. When the activationwire 112 is pulled (by the handle 1002), clips 108 are rotated and thus,their sharp edge 720 penetrates the tissue 501 (FIG. 7M). Once the sharpedge 720 penetrates the tissue 501, the clip 108 can be detached fromthe FA 104 (FIG. 7N). The detachment can be obtained by extracting thepin 721 from the clip 108.

Another option for the detachment is by the rotational motion of theclip 108 itself. In this case the clip 108 is attached to the FA 104 bya screw. The rotational motion needed for the attachment of the clip tothe tissue will also be used for detaching (by unscrewing) the clip fromthe FA 104.

Reference is now made to FIGS. 8A-8F which illustrate severalalternative embodiments for the connection between the activation wire112 and the clip 108. One option to connect the activation wire 112 andthe clip 108 is as described in FIG. 8A. The activation wire can enterthe connection point 404 (which can be an aperture) and glued or tied toit. Another option is demonstrated in FIG. 8B in which the activationwire is glued parallel to the connection point which has a rectangularprofile providing sufficient attachment surface. FIG. 8C representsanother alternative in which a number of apertures are provided. Theactivation wire 112 can enter the apertures in a zig-zag form or backand forth look thereby providing a glue-less attachment. FIGS. 8D-8Frepresent another possible embodiment for the connection between theactivation wire 112 and the connection point 404. According to thisembodiment, a fork like portion 404 encapsulates the wire 112.

Once the patch 106 is attached to the tissue 501 the stretching wire 107and the activation wire 112 are cut.

Reference is now made to FIGS. 9A-9D which represent one possibleembodiment implementing a mechanism 901 for cutting the activation wire112 and the stretching wire 107. Those figures illustrate a crosssection view of the cutting mechanism 901. As can be seen from thefigures, the cutting mechanism 901 is located at the distal end of tube103. This location was chosen for two reasons: (i) the fact that theedge of the activation wire 112 should be as shorter as possible oncethe wire has been cut (this leftover from the wire remain in the body,therefore it is preferable that the leftover would be as short aspossible); and, (ii) the fact that the stretching wire 107 is pulled outof the body. In order to extract the wire 107, it has to pass towardsthe patch and through the perimeter of the patch. To enable an easyextraction of wire 107 it is preferred to cut the wire as close aspossible to the patch—i.e. in the distal end of tube 103.

FIGS. 9A-9B illustrate a 3D cross section of the cutting mechanism 901and FIGS. 9C-9D illustrate a 2D cross section of the cutting mechanism901.

The cutting mechanism 901 comprises a dedicated cutting pin 902 isplaced inside tube 103 near the distal end. The cutting pin 902 isconnected to the distal end of a cutting activation wire 903. Theproximal end of the cutting activation wire 903 is connected to theproximal portion 102 of device 100. Pulling the cutting activation wire903 will result in a reciprocate movement of the cutting pin 902 (whichis parallel to tube 103 longitudinal axis).

Both the cutting pin 902 and the tube 103 have lateral holes (904 and905 respectfully) through which the activation wire 112 and\or thestretching wire 107 are passing through. Furthermore the activation wire112 and the stretching wire 107 can move freely inside the holes (904and 905). Once the patch 106 is attached to the tissue 501 the physiciannow needs to cut both the activation wire and the stretching wire. Inorder to cut those wires the physician will press the cutting handle 115(the handle will be discussed in further details in FIG. 10) at theproximal portion 102. As a result the cutting activation wire 903 andthe cutting pin 902 will be pulled toward the proximal portion 102 and ashear force will be implemented on the activation wire 112 and/or thestretching wire 107, hence cutting them to two sections as illustratedin FIG. 9B.

It is further in the scope of the present invention wherein a singlemechanism is adapted to cut both the activation wire 112 and thestretching wire 107. It is further in the scope of the present inventionwherein two separate mechanisms are adapted to cut the activation wire112 and the stretching wire 107.

In a preferred embodiment of the present invention, at least a portionof the activation wire remains within the body, thereby providingadditional fixation to the clips. This additional fixation is needed incase one of the clips detaches from the patch and may wander inside thebody, causing complications.

It is in the scope of the present invention wherein the entireactivation wire 112 detaches from the clips 108 and extracted from thebody.

Reference is now made to FIGS. 10A-10E which represent the proximalportion 102 in different stages of the deployment and the attachment. Ascan be seen from the figure, the proximal end 102 can comprises numeroushandles. A dedicated handle 113 is adapted to reversibly transform theFAs 104 from their close stage (initial stage) to their open stage(final stage). A second handle 1001 is adapted to activate clips 108such that the patch 106 is at least partially attached to the tissue 501by pulling the activation wire 112. Handle 1002 is adapted to releasethe patch 106 from the FAs by cutting the stretching wire 107. Handle1002 is also adapted to cut the activation wire 112. Button 1003 isadapted to release handle 113 such that the FAs 104 return to theirclose stage.

FIG. 10A illustrates the initial stage at which none of the handles arepressed. In figure. 10B, handle 113 is presses thereby transforming theFAs 104 from the close stage to the open stage thereby deploying thepatch 106. After the patch 106 is deployed, the physician can move androtate the deployed patch 106. This is preformed in order to bring saidpatch adjacent to the tissue. The physician can apply pressure neededfor the attachment process.

When the patch is located adjacent to the tissue, handle 1001 is presses(FIG. 10C) thereby activating the clips (by pulling the activation wire112) and the patch is now attached to the tissue. After the patch issecurably attached to the tissue, handle 115 is presses, thereby thecutting the stretching wire 107 and the activation wire 112 (FIG. 10D).Now the patch is released from the FAs 104 and the FAs can return to theclose stage and be extracted from the body (by pressing on button 1002,FIG. 10E).

It is in the scope of the present invention wherein the device 100 whichis adapted to deploy and attach a patch is useful in minimal invasiveheart surgeries for attaching a patch to the heart, for preventing heartfailure due to aneurysm.

It is in the scope of the present invention wherein the device 100 whichis adapted to deploy and attach a patch is useful in endoscopic colonsurgeries.

It is another object of the present invention to provide a deploymentand attachment device in which clips 108 are at least partiallyconnected to the patch (instead of the FA) prior to the attachment. Inthis embodiment the clips 108 are initially coupled to the patch and notto the FAs. Furthermore, in this embodiment the role of the FAs is todeploy the patch and to press it against the tissue.

Reference is now being made to FIGS. 11 and 12A-12G which describedifferent coupling means between the patch 106 and the FAs 104.

One of the advantages of the coupling means is the fact that no wiresare used. Thus, enabling fast and simple mounting of the patch 106 ontop of the FAs 104 during surgery.

The coupling is based on dedicated patch-FA clips 1201 which areconnected to the FAs 104.

Reference is now made to FIG. 12A which presents a closer view of theclip 1201. The clip 1201 has a main portion 1202 and at least oneflexible branches 1203 extruding (or protruding) out from the mainportion 1202. When the branches 1203 are not subjected to external load,they buckle laterally, therefore, provide attachment between the FA 104and the patch 106.

Reference is now made to FIGS. 12A-12C which describe the method ofde-activating the clip 1201 (i.e., disconnecting the clip 1201 from thepatch 106).

Once the patch 106 is attached to the tissue 501, the user coulddisconnect the patch by pulling the FA 104 away from the tissue. As aresult the branches 1203 are deformed (from a position being parallel tothe tissue to a portion being perpendicular to the same). Thus, thebranches 1203 pass through their entrance hole at the patch 106 (FIG.12A) and are disconnected from the patch.

Once the clips 1201 are disconnected from the patch it resumes itsoriginal shape (in which the branches 1203 are in a parallelposition)—see FIG. 12C.

According to one embodiment of the present invention, in order to allowcorrect folding and unfolding of the patch 106, without the creation oftension on the patch 106 and on the FA 104, some of the clips 1201 couldmove freely along the FA 104, while others will be fixed to their place.

FIGS. 12D-12G describes the process of mounting the patch 106 on thedeployment system. In order to enable simple insertion of the clip 1201through the patch 106, the clips 1201 are delivered to the user togetherwith a sharp cap (i.e., envelope covering) 1204 as can be seen from FIG.12D.

The cap will accommodate the branches 1203 in a vertically alignment (inrelation to the FA 104). In a preferred embodiment, the user (a surgeonor a nurse) will insert the cap 1204 whilst accommodating the clip 1201through the patch during the surgery (see FIG. 12E). Once all the clips1201 are inserted through the patch the caps 1204 are removed from eachindividual clip 1201 (see FIG. 12F). As a result the branches 1203buckle laterally (i.e., into a parallel position in relation to thetissue). Thus, providing attachment between FA 104 and the patch 106(see FIG. 12G).

FIGS. 12H-12J illustrate an alternative approach of mounting the patch106 on the deployment system. According to this approach, the clip 1201comprises two separate portions: (a) a main portion 1205 which isconnected the FA 104; and, (b) a second portion 1206. Portion 1206 haveat least one branch 1208 connected to a pressing area 1207. Initially,the branches 1208 are partially inserted into a channel within the mainportion 1205, such that they are vertically aligned, and their distalend protrudes out from the top end of the main portion 1205 (see FIG.12I). The main role of portion 1205 is to retain the branches 1208 frombuckling laterally.

Said attachment between patch 106 and FAs 104 is obtained by insertingthe patch 106 through the branches 1208 (see FIG. 12I) and then portion1206 is pressed upward, toward the patch. The branches, which is nolonger confined by the main portion 1205, buckle laterally, thus providethe said attachment between patch 106 and FA 104 (see FIG. 12J).

FIGS. 12K-12Q describe another alternative approach of mounting thepatch 106 on the deployment system. In this approach, the branches 1208of each clip are bended radially, toward or away the center of the patch(see FIG. 12K).

Once the patch 106 is attached to the tissue 501, the FAs 104 areclosed. As a result the branches 1208 move radially, therefore,disconnecting form the patch 106, as can be seen at FIGS. 12M-12Q. In apreferred embodiment, the mounting process of patch 106 on top FAs 104is similar to the previously described approach as can be seen in FIGS.12N-12P

Reference is now being made to FIGS. 13A-13F which describes analternative embodiment for attaching patch 106 to the tissue 501 byseveral clips 108. In this embodiment, as can be seen in FIG. 13A andFIG. 13D, the clip 108 is connected to a wire 1301 which is incorporatedwithin the patch 106. The connection between clip 108 and wire 1301 isat a wire connection area 1306 and will enable free rotation of the clip108 around the wire 1301.

The clip 108 will have a central plate 1305 and at least two sharp arms1304 connected to each side of the plate. In a preferred embodiment, thearms 1304 are curved. An activation wire 1302 will be coupled to theplate 1305. Once the wire 1302 is pulled, during surgery, the entireclip 108 is rotated around wire 1301.

The activation wires 1302 from each clip 108 will be connected to acentral activation area 1303 (see FIG. 13B) which will pull all theactivation wires 1302 toward the center of the patch 106 once theattachment between patch 106 and tissue 501 is needed. The centralactivation area 1303 will be activated by pulling the clip activationwire 112, or by rotating the central shaft 105.

As can be seen in FIGS. 13B and 13E, once the central activation area1303 is activated, each activation wire 1302 is pulled toward thecenter, therefore inducing rotational movement of each of the clips 108around wire 1301. As a result, the arms 1304 (of each clip 108), areinserted through the patch 106 and the tissue 501. Thus, providingattachment between the tissue 501 and the patch 106.

Once the attachment (between the patch and the tissue) is achieved, thewire 1302 is disconnected from the central activation area 1303 in orderto enable proper detachment between the connected patch 106 and the restof the deployment system.

In a preferred embodiment of the current invention the connectionbetween clip 108 and the activation wire 1302 is considerably weakerthan the rest of the wire 1302 but strong enough to rotate the clip 108.Once the clip is fully inserted into the tissue, the activation wirewill be pulled using sufficient force for disconnecting it for the clip108 (FIG. 13C, 13F). In other words, pulling the activation wire 1302 inF amount of force enables the insertion of the clip 108 into the tissue;and, pull the activation wire 1302 in F1 amount of force (F1 issufficiently greater than F) enables the disconnection of the activationwire 1302 from clip 108.

Reference is now being made for FIGS. 14A-14D which describe analternative detachment mechanism between the patch 106 and the FAs 104.According to this embodiment, the central shaft 105 is extended from theproximal side of handle 102 (FIG. 14A), therefore the unfolding processcan be achieved be pulling the central shaft proximally.

The distal end of shaft 105 is inserted to a sleeve 1401 located at thedistal end on the FAs 104. The sleeve 1401 have two lateral holes 1402initially concentric to a hole 1403 at the distal end of the centralshaft. When hole 1402 and hole 1403 are aligned, the stretching wire 107can pass through them (see FIG. 14C).

The stretching wire is kept constantly in tension, therefore keeps asufficient tension applied on the patch 106 during the unfoldingprocess, and prevents wrinkles. Once the patch 106 is attached to thetissue 501, the user will rotate handle 1404 which is located at theproximal end of the central shaft 105 (FIG. 14B). This rotationalmovement cuts the stretching wire 107 at the distal end of the centralshaft 105 (FIG. 14D). This cutting cuts the stretching wire 107 into twohalfs (sections). Since there the stretching wire 107 are tensed, thetwo ends of the already cut wire 107 will be instantly pulled toward theproximal end of the system, therefore canceling the attachment betweenpatch 106 and the FAs 104.

In the foregoing description, embodiments of the invention, includingpreferred embodiments, have been presented for the purpose ofillustration and description. They are not intended to be exhaustive orto limit the invention to the precise form disclosed. Obviousmodifications or variations are possible in light of the aboveteachings. The embodiments were chosen and described to provide the bestillustration of the principals of the invention and its practicalapplication, and to enable one of ordinary skill in the art to utilizethe invention in various embodiments and with various modifications asare suited to the particular use contemplated. All such modificationsand variations are within the scope of the invention as determined bythe appended claims when interpreted in accordance with the breadth theyare fairly, legally, and equitably entitled.

Reference is now made to FIGS. 15A-15D which illustrate an embodiment inwhich the patch can be laterally rotate with respect to the tissue suchthat the right orientation of the patch is facing the tissue or thehernia.

Reference is now being made for FIGS. 15A-15B, which describes anembodiment in which at least a part of tube 103 is a controllable andflexible joint 1502. This joint is especially adapted to allow fineadjustment of the lateral angle between distal portion 101 and theproximal portion 102 during the procedure.

In other words, the controllable and flexible joint is provided in orderto adjust the right orientation of the patch with regards to the tissueor the hernia.

Such adjustment is needed in order to aline the patch 106 with adesirable lateral position with regards to tissue 501. According to thisembodiment, the controllable and flexible joint 1502 is made of flexiblematerial (e.g. polymer) and can be curved according to predeterminedangle in its distal end. The controllable and flexible joint 1502 ishoused by a rigid alignment tube 1501. Said rigid alignment tube 1501can be reciprocally moved along it longitudinal axis.

It should be emphasized that the controllable and flexible joint 1502has an intrinsic spring-like properties; i.e., the controllable andflexible joint 1502, when is unloaded, returns to its originalcurved/bent shape.

At the initial state (FIG. 15A) the controllable and flexible joint 1502is completely encapsulated within the rigid alignment tube 1501 suchthat controllable and flexible joint 1502 it forced to be straight andlinear, once the distal portion 101 is inserted into the patient bodyand lateral angle adjustment is required, the rigid alignment tube 1501is pulled toward the proximal portion 102; as a result, the controllableand flexible joint 1502, which is no longer supported by the rigidalignment tube 1501, is bent/curved into its original form, thusproviding the desire angle between the proximal portion 102 and thedistal portion 101 (FIG. 15B).

By controlling the location of the rigid alignment tube 1501 withrespect to the controllable/flexible joint 103, a fine adjustment of theangle is obtained. As mentioned above, the control over the rigidalignment tube's 1501 location is provided by the amount of pulling orpushing of said rigid alignment tube 1501 towards and away from theproximal portion 102.

Since the surgeon controls said rigid alignment tube's 1501 location, hetherefore controls the angle between the distal portion 101 and proximalportion 102.

The movement (and thus the angle between the distal portion 101 andproximal portion 102) is adjusted by the angle control means 1502 whichis located at the proximal portion 102.

Reference is now made to FIGS. 15C-15D which illustrate a top view ofthe system. In FIG. 15C the rigid alignment tube 1501 is fullyhousing/encapsulating the controllable and flexible joint 1502 and thusthe angle between the distal portion 101 and proximal portion 102 is 0degrees.

FIG. 15D also illustrates a top view of the system. However, in FIG. 15Dthe rigid alignment tube 1501 is not fully housing/encapsulating thecontrollable and flexible joint 1502, thus the controllable and flexiblejoint 1502 is curved/bent according to the location of the rigidalignment tube's 1501 with respect to the controllable and flexiblejoint 1502. Therefore, an angle A is obtained between the distal portion101 and proximal portion 102.

Reference is now being made to FIGS. 16A-16C which describe anembodiment of the patch insertion sleeve. Such a sleeve/cover is neededin order to facilitate, to ease and to catalyze the insertion of thedistal end 101 and the patch 106 in to the patient's body.

According to this embodiment the insertion sleeve 1601 is an elongatedrigid tube with a cone shaped expansion 1602 at its proximal end and astopper 1603 near its distal end. Once the patch 106 is mounted andfolded on the distal portion 101 (during the surgery or during theassembly process prior to the surgery), it is inserted, together withthe distal portion 101, into the insertion sleeve 1601 trough the coneshape expansion 1602, such that the distal end of the insertion sleeve1601 reaches the distal end of the distal portion 101 (FIG. 16B).

The overall complex is then inserted to the patient's body through atrocar 114. The outside diameter of the insertion sleeve 1601 at theportion between its distal end and the stopper 1603 is smaller or equalto the inside diameter of the trocar 114, such that this portion can beinserted into the trocar 114. Once the stopper 1603 reaches the trocar114 proximal end, the distal portion 101 and the patch 106 slide out ofthe insertion sleeve and into the trocar 114 and the patent body, whilethe insertion sleeve is slide backward along the rigid alignment tube1501 or the tube 103. At the final stage (FIG. 16C), the distal portion101 and the patch 106 is completely inserted into the patient's body.

Reference is now being made to FIGS. 18A-18D which illustrate anadditional embodiment of the deployment mechanism. This embodimentprovides larger patches deployment using the same initial length of thedistal portion 101; in addition, it will allow a simpler reversibleattachment between patch 106 and the distal FA 104.

According to this embodiment each FA 104 additionally comprises a longrod 1801 which is aligned parallel to the central shaft. The rods 1801are connected to the FA 104 via at least one joint or flexible portion.

According to this embodiment, the patch 106 is reversibly connected tothe rods 1801 rather than the FAs 104. The patch 106 is deployed by areciprocal movement of the central shaft 105 toward the proximalportion. As a result, the rods 1801 are laterally moved away from eachother, providing patch deployment.

FIG. 18D illustrate the above embodiment incorporated with the patch106.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

1. (canceled)
 2. A method for closing an aperture in a biological tissuecomprising; inserting an instrument into a surgical site of a patient,the instrument having: an elongate shaft having a longitudinal axisextending therethrough, a deployment scaffold connected to the elongateshaft and configured to releasably retain a surgical implant, thedeployment scaffold including: a plurality of deployment armstransitionable between a closed position and at least one deployedposition, and a plurality of attachment members releasably connected tothe deployment arms, the attachment members configured to attach thesurgical implant to the deployment scaffold; deploying the surgicalimplant; and releasing the surgical implant from the instrument in aradial direction relative to the longitudinal axis.
 3. The method ofclaim 2, further comprising using the deployment scaffold to attach thesurgical implant to the biological tissue, thereby covering the aperturein the biological tissue.
 4. The method of claim 2, wherein insertingthe instrument further comprises a central shaft disposed within theelongate shaft and the deployment scaffold coupled to the elongateshaft.
 5. The method of claim 4, wherein inserting the instrumentfurther comprises transitioning the deployment scaffold between an openform and a closed form in response to movement of the central shafttowards a handle coupled to the elongate shaft.
 6. The method of claim3, wherein prior to using the deployment scaffold, the method includesadjusting a position and an orientation of the surgical implant relativeto the aperture in the biological tissue.
 7. The method of claim 2,wherein the aperture in the biological tissue is an aperture in anabdominal wall.
 8. The method of claim 3, wherein prior to using thedeployment scaffold, the method further includes: assessing deploymentof the surgical implant relative to the aperture in the biologicaltissue; retracting the surgical implant; and re-deploying the surgicalimplant.
 9. The method of claim 3, wherein using the deployment scaffoldand releasing the surgical implant are conducted sequentially.
 10. Themethod of claim 3, wherein using the deployment scaffold and releasingthe surgical implant are conducted simultaneously.
 11. The method ofclaim 2, wherein inserting the instrument includes the surgical implantbeing a surgical mesh.
 12. The method of claim 2, wherein inserting theinstrument includes the attachment members selected from the groupconsisting of: clips, hooks, and barbs.
 13. The method of claim 2,wherein inserting the instrument includes the plurality of deploymentarms hingedly connected to a frame and the frame configured to move fromthe closed position to the at least one deployed position.
 14. Themethod of claim 2, wherein deploying the surgical implant includes aplurality of deployment positions for the deployment scaffold.
 15. Themethod of claim 6, wherein inserting the instrument includes anarticulating member associated with the deployment scaffold to allow foradjustment of the position and the orientation of the surgical implantrelative to the aperture in the biological tissue.
 16. The method ofclaim 15, wherein inserting the instrument includes the articulatingmember allowing vertical flexibility of the deployment scaffold in orderto press the surgical implant against the biological tissue.
 17. Themethod of claim 2, wherein releasing the surgical implant from theinstrument includes rotating the attachment members.
 18. The method ofclaim 2, wherein deploying the surgical implant is accomplished in acontrolled and continuous manner.